MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K081121
Device Name MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 shorebird way
mountain view, 
CA 
94043

Applicant Contact martina vogt
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 shorebird way
mountain view, 
CA 
94043

Correspodent Contact martina vogt
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received 04/21/2008
Decision Date 06/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No